MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2 APPLICATION; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71926-01

Device Problems Computer Software Problem (1112); Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2023

Event Type  Injury  

Event Description

Abbott diabetes care (adc) received a complaint via social media which reported an "incompatible os or incompatible device" issue with freestyle 2 application.The customer indicated in their post that "i could have died last night" however, did not provide additional information as the customer abandoned their social media post.No further information was obtained.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care (adc) received a complaint via social media which reported an "incompatible os or incompatible device" issue with freestyle 2 application.The customer indicated in their post that "i could have died last night" however, did not provide additional information as the customer abandoned their social media post.No further information was obtained.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and it has been determined that there were no issues with the freestyle libre 2 that would have led to the complaint.The user reported incompatible operating system version with the freestyle libre 2 application.Attempted to replicate the issue using a similar configuration, and was unable to reproduce the complaint.Therefore, the complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2 APPLICATION
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17134660
• MDR Text Key: 317230327
• Report Number: 2954323-2023-25377
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71926-01
• Device Catalogue Number: 71926-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female